Cryoablation for Benign Gastrointestinal Anastomotic Strictures

Esophageal Stricture Clinical Trial

Official title:

A Randomized Controlled Trial of Cryotherapy on Benign Anastomotic Strictures Following Esophagectomy, Gastrectomy, and Bariatric Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04372784
• Other study ID #: HS-19-00679
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2020
• Est. completion date: December 2022

Study information

• Verified date: May 2020
• Source: University of Southern California
• Contact: Kulmeet Sandhu, MD
• Phone: 323 442 5831
• Email: kulmeet.sandhu[@]med.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Anastomotic stricture is a common complication following foregut surgery. The standard of care for these benign foregut anastomotic strictures is balloon dilatation. However, re-stenosis of strictures is also common, requiring frequent repetition of balloon dilatation. Cryotherapy is a novel therapy that may improve clinical outcomes following dilatation. The purpose of the present study is to conduct a randomized controlled trial to characterize the impact of cryotherapy on clinical outcomes and complications for benign anastomotic strictures following esophagectomy, gastrectomy, and bariatric surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Critieria

• History of esophagectomywith primary anastomosis

• History of gastrectomy with primary anastomosis

• History of bariatric surgery with primary anastomosis

• History of anastomotic stricture

• History of balloon dilatation at Keck Hospital of the University of Southern California

Exclusion Critieria

• Patients treated at medical centers other than Keck Hospital of the University of Southern California

• History of anastomotic stent placement

Related Conditions & MeSH terms

• Anastomotic Stricture of Small Intestine
• Constriction, Pathologic
• Duodenal Stricture
• Esophageal Stenosis
• Esophageal Stricture
• Jejunal Stricture

Intervention

Device:
• Cryotherapy
Cryotherapy entails introducing a 9 French catheter via the endoscope's accessory port. The catheter is advanced until it is visualized on the endoscopy monitor. Under 4 psi pressure, liquid nitrogen is sprayed from the catheter for twenty seconds over each four-centimeter segment of stricture

Procedure:
• Esophagogastroduodenoscopy with Balloon Dilatation
This procedure entails deploying a balloon via the accessory port of the esophagogastroduodenoscope under direct visualization and serially inflating the balloon. Balloon dilatation disrupts not only the muscular rings surrounding strictures but also the granulation tissue composing the strictures.

Locations

Country	Name	City	State
United States	Keck Hospital of USC	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Dilatations	Total number of dilations within one year	One year
Secondary	Dilatation size	Dilatation size (as a proportion to size at presentation)	Immediately after the intervention/procedure/surgery/etc
Secondary	Perforation rate	Rates of hollow viscus perforation	Immediately after the intervention/procedure/surgery/etc
Secondary	Bleeding rate	Rates of clinically significant bleeding	Immediately after the intervention/procedure/surgery/etc
Secondary	Fistula rate	Rates of fistula formation	One year
Secondary	Reintervention	Rates of unplanned reintervention (e.g., stenting)	One year
Secondary	Readmission	Rates of readmission	One year